510(k) K161602 ยท DWJ System, Thermal Regulating
Arctic Sun Temperature Management System
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Sep 2, 2016 |
| Received | Jun 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2024 | Medivance Inc. Arctic Sun Temperature Management Systems, Name/REF:
Arctic Sun STAT, NA/6000-00-00;
Arctic Sun STAT Loaner, NA/6000-00-00L;
Arctic Sun Stat EU UK/600001;
Arctic Sun Stat Taiwan/600006;
Arctic Sun St Open, Classified |
DWJ | None listed |
| Jun 13, 2018 | Bard Medical Division Arctic Sun Temperature Management System, Model 5000.
The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a ra Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.